Followed by the negative opinion, Ipsen will be requesting a re-examination of the CHMP opinion, based on existing data of palovarotene clinical trial program (MOVE)
The CHMP opinion is based on the data of the P-III study (MOVE, NCT03312634), evaluated the efficacy and safety of palovarotene (5mg, QD, oral) and episodic (20mg, QD for 4wks., followed by 10mg for ≥8wks, for flare-ups and trauma) in patients (n=107) with FOP
1EPs were to evaluate the safety and efficacy of palovarotene in reducing new HO volume, as measured by whole-body CT vs patients untreated beyond SoC from Ipsen’s global FOP natural history study
Ref: BusinessWire | Image: Ipsen
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